ViiV Healthcare has reported interim analysis data from the LATITUDE Phase III clinical trial of its long-acting injectable antiretroviral treatment (ART) Cabenuva in HIV patients with adherence challenges.
Cabenuva is a combination of cabotegravir and rilpivirine.
The LATITUDE trial, which is still in progress, spans 31 sites across the US, including Puerto Rico.
It specifically involves subjects who have struggled with adhering to a daily oral ART regimen and have shown evidence of viremia.
Before the randomisation into the trial, these individuals received support designed to enhance adherence while they took a three-drug regimen oral ART, including dolutegravir and bictegravir-based treatments, to achieve viral suppression.
Upon reaching this milestone, they were randomised to either continue with their daily oral ART or switch to the long-acting injectable ART comprising cabotegravir and rilpivirine, administered every four weeks.
The Data Safety Monitoring Board (DSMB) conducted a planned interim review recently.
After evaluating all study endpoints, the DSMB concluded that the long-acting ART demonstrated efficacy over the standard daily oral care.
Cabenuva was superior in maintaining viral load suppression versus oral therapy.
Based on these findings, the board also recommended that all eligible subjects be offered treatment with Cabenuva.
The US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) is funding and sponsoring the LATITUDE trial.
The Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) is implementing the study with support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare, and Janssen.
ViiV Healthcare R&D head Kimberly Smith said: “The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome.
“There are many reasons why people may find it challenging to stay on daily oral treatment and the LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed, which benefits their overall health. Optimising therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”
